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出境医 / 临床实验 / The Early Diagnosis of Pulmonary Nodule Based on Multi-dimension Messages
The Early Diagnosis of Pulmonary Nodule Based on Multi-dimension Messages
Study Description
Brief Summary:
The researchers are aimed to investigate the early diagnosis of pulmonary nodule based on DNA, RNA, protein, metabolites through analyzing the serum, urine and clinical characteristics.
| Condition or disease | Intervention/treatment |
|---|---|
| Pulmonary Nodule, Solitary Lung; Node | Diagnostic Test: The serum and urine from people enrolled are used to analyze the DNA, RNA, protein, metabolites, immune status |
Detailed Description:
By recruiting people with pulmonary nodules identified by CT scans, three groups are confirmed as the lung cancer group, the benign lung nodule group who are identified by pathological analysis, and the small lung nodule group that should be followed up. Then the serum, the urine and the clinical characteristics including age, sex, smoking status, BMI, address, greening environment are collected to analyze the ctDNA, RNA, protein, metabolites, immune status and their relationships with the tumorigenesis and the gene mutation of lung cancer.
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Official Title: | The Early Diagnosis of Pulmonary Nodule Based on Multi-dimension Messages |
| Actual Study Start Date : | July 1, 2018 |
| Estimated Primary Completion Date : | December 31, 2020 |
| Estimated Study Completion Date : | December 31, 2021 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
| lung cancer |
Diagnostic Test: The serum and urine from people enrolled are used to analyze the DNA, RNA, protein, metabolites, immune status
The serum and urine from people enrolled are used to analyze the DNA, RNA, protein, metabolites, immune status
|
| benign lung nodule |
Diagnostic Test: The serum and urine from people enrolled are used to analyze the DNA, RNA, protein, metabolites, immune status
The serum and urine from people enrolled are used to analyze the DNA, RNA, protein, metabolites, immune status
|
| lung nodule |
Diagnostic Test: The serum and urine from people enrolled are used to analyze the DNA, RNA, protein, metabolites, immune status
The serum and urine from people enrolled are used to analyze the DNA, RNA, protein, metabolites, immune status
|
Outcome Measures
Primary Outcome Measures :
- Up-regulation of ctDNA [ Time Frame: the first day subjects are enrolled the outcome will be assessed ]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects enrolled are volenteered and are willing to be followed up.
Criteria
Inclusion Criteria:
For lung cancer groups
- (1) Patients diagnosed with lung cancer;
- (2) Clear diagnosis by pathological examination to determine pathological type;
- (3) Those aged 18-80 years old;
- (4) For patients with newly diagnosed lung cancer, CT confirmed that the size of primary lung cancer is ≤ 3 cm;
- (5) The patient or family member agrees to participate in the study and sign an informed consent form;
- (6) No other serious cardiopulmonary diseases. For lung nodule
- (1) Those aged 18-80 years;
- (2) CT clear lung nodule size ≤ 3cm;
- (3) 1-3cm pulmonary nodules confirmed by pathological diagnosis as non-lung cancer or other metastatic cancer patients or ≤1cm pulmonary nodules
- (4) The patient or family member agrees to participate in the study and sign an informed consent form;
- (5) No other serious cardiopulmonary diseases.
Exclusion Criteria:
- (1) Women who are breast-feeding, pregnant or preparing for pregnancy;
- (2) Those who are allergic to allergies and multiple drugs;
- (3) Combining severe primary diseases such as cardiovascular and cerebrovascular, liver, kidney, and hematopoietic system, as well as subjects with mental illness;
- (4) concurrently infected;
- (5) Those who participated in other clinical trials within three months.
Contacts and Locations
Contacts
| Contact: jinshuo fan | +8615827367482 | whxhfjs@hust.edu.cn |
Locations
| China, Hubei | |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting |
| Wuhan, Hubei, China, 430000 | |
| Contact: Yang Jin, MD | |
Sponsors and Collaborators
Wuhan Union Hospital, China
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 23, 2019 | ||||
| First Posted Date | July 2, 2019 | ||||
| Last Update Posted Date | July 2, 2019 | ||||
| Actual Study Start Date | July 1, 2018 | ||||
| Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Up-regulation of ctDNA [ Time Frame: the first day subjects are enrolled the outcome will be assessed ] | ||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | The Early Diagnosis of Pulmonary Nodule Based on Multi-dimension Messages | ||||
| Official Title | The Early Diagnosis of Pulmonary Nodule Based on Multi-dimension Messages | ||||
| Brief Summary | The researchers are aimed to investigate the early diagnosis of pulmonary nodule based on DNA, RNA, protein, metabolites through analyzing the serum, urine and clinical characteristics. | ||||
| Detailed Description | By recruiting people with pulmonary nodules identified by CT scans, three groups are confirmed as the lung cancer group, the benign lung nodule group who are identified by pathological analysis, and the small lung nodule group that should be followed up. Then the serum, the urine and the clinical characteristics including age, sex, smoking status, BMI, address, greening environment are collected to analyze the ctDNA, RNA, protein, metabolites, immune status and their relationships with the tumorigenesis and the gene mutation of lung cancer. | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Subjects enrolled are volenteered and are willing to be followed up. | ||||
| Condition |
|
||||
| Intervention | Diagnostic Test: The serum and urine from people enrolled are used to analyze the DNA, RNA, protein, metabolites, immune status
The serum and urine from people enrolled are used to analyze the DNA, RNA, protein, metabolites, immune status
|
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| Study Groups/Cohorts |
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
500 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 31, 2021 | ||||
| Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria: For lung cancer groups
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years to 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts |
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| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04005677 | ||||
| Other Study ID Numbers | Whuh2019 v.1 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Yang Jin, Wuhan Union Hospital, China | ||||
| Study Sponsor | Wuhan Union Hospital, China | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Wuhan Union Hospital, China | ||||
| Verification Date | June 2019 | ||||
